Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-03-27

Brief Summary

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Dysautonomia in post-covid-19 condition appears to affect a significant number of patients, with reports raising the incidence up to 61%, having an overlap with myalgic encephalomyelitis/ chronic fatigue syndrome. Quality of life and daily function is significantly impacted and conservative management interventions, despite the lack of high quality evidence up to now, are needed to ameliorate disability. 50 adults with a dysautonomia post-covid-19 diagnosis based on the Ewing battery and a NASA lean test will be enrolled in a randomized single blinded controlled trial with a crossover design. Feasibility and lack of definite dysautonomia diagnosis will be the primary out-comes, while secondary outcomes will be health-related, clinical and cardiopulmonary exercise test indicators. Safety and acceptance will also be checked, primarily excluding participants with post exertional malaise. The Long-CoViD patients Causal Diagnosis and Rehabilitation study in patients with Dysautonomia (LoCoDiRE-Dys) study intervention will consist of an educational module, breathing retraining and an individualized exercise intervention of biweekly sessions for two months with regular assessment of both groups. LoCoDiRe- Dys aims to be the first post-covid-19 randomized study in people with dysautonomia offering a multimodal intervention both in diagnosis and management

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Detailed Description

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Conditions

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Post-Acute COVID-19 Syndrome Dysautonomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

unblinded randomized controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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LoCoDiRe-Dys

Respiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type PROCEDURE

respiratory physiotherapy, personalized aerobic and strength training

Standard of Care

Intervention Type PROCEDURE

Behavioural and Medical management

Standard of Care

Standard of care including behavioural and medical advice

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type PROCEDURE

Behavioural and Medical management

Interventions

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Rehabilitation

respiratory physiotherapy, personalized aerobic and strength training

Intervention Type PROCEDURE

Standard of Care

Behavioural and Medical management

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults 18-65 years of age
* WHO definition of post covid-19 condition
* Confirmed dysautonomia diagnosis through Ewing Battery
* Able to attend 2 times/ week for 8 weeks
* Able to provide informed consent

Exclusion Criteria

* Absolute or relative contra-indications to exercise due to cardiac pathology
* Serious mental/ cognitive impairment that will not allow systematic participation
* Unable to regularly reach the center
* Pregnancy
* CFS/ME fulfilling the Canadian Consensus Criteria
* Secondary health conditions that would explain symptoms, intervene in dysautonomia diagnosis or would impede participation in the exercise protocol (i.e. , untreated hypothyroidism and Diabetes Melitus, major psychiatric disorders, COPD, PICS, Pulmonary Fibrosis, chronic respiratory or heart failure, not ambulatory, suffering from dementia, chronically paralyzed, with paraplegia, with multiple injuries or other serious orthopedic problems that caused disability, patients suffering from very serious underlying diseases such as end-stage cancer, and those with neurological diseases causing disability)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No